Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Foreign Priority
The present application claims priority to the applications, JP2021-081310 and PCT/JP2022/020078, with effective filing dates of 12 May 2021 and 12 May 2022, respectively.
Claim Status
This Office Action is in response to Applicant’s Amendment filed, 14 February 2024, wherein Applicant canceled claim 1 and added new claims 10-13.
Claims 10-13 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 14 February 2024 and the references cited therein have been considered, unless indicated otherwise.
The references, wherein a copy was provided but is illegible, are lined through. These references are the following: Ishida (Fragrance Journal, 2004, 32(11), 23-32); Sugiyama (Fragrance Journal, 2006, 34(10), 19-23); Hirao (Fragrance Journal, 2000, 17, 14-19); Furuse (Journal of Japanese Cosmetic Science Society, 2007, 31, 296-301); and Kaneko (Journal of Traditional Medicines, 1998, 15, 302-303).
The references, wherein a copy was not provided, are lined through. These references are the following: JP2003-306408; Yasuda (Folia Pharmacologica Japonica, 2005, 125(6), 370-384); and Lavker (Journal of Cell Biology, 1979, 73(1), 59-66).
Claim Interpretation
Claims 10-13 recite a method of preventing or ameliorating metabolic syndrome. For purposes of clarity, the Examiner interprets this to be Syndrome X, insulin resistance syndrome, or dysmetabolic syndrome, as defined by Cleveland Clinic (page 2, bullet points 1-3; “Metabolic Syndrome,” Cleveland Clinic, 13 Sept 2023, <my.clevelandclinic.org/health/diseases/10783-metabolic-syndrome>, accessed 14 Jan 2026). Additionally, Cleveland Clinic specifies that metabolic syndrome is a group of conditions that increase the risk of cardiovascular disease, Type 2 diabetes, and stroke (page 1, paragraph 2). These conditions are excess abdominal weight, hypertriglyceridemia, low levels of HDL cholesterol, elevated blood sugar levels, and high blood pressure and that possessing three or more of the conditions significantly increases risk of cardiovascular disease, Type 2 diabetes, and stroke (page 2, bullet points 4-9; page 2, paragraph 2). Additionally, Khushwaha (Obesity Medicines, 2019, 14(100084), 1-4) teaches prevention of metabolic syndrome via administration of the small molecule, sitagliptin through inhibition of DPP IV, which prevents progression of obesity from predisposed factors and prevents the breakdown of GLP-1 (page 2, column 1, paragraph 2; page 3, column 2, paragraph 2). Muñoz-Garach (Nutrients, 2016, 8(320), 1-10) teaches metabolically healthy obese people exist (page 1, paragraph 1; page 6, paragraph 4).
Additionally, claims 10-13 recite the following compounds:
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. Compound 1 has the following names: 3-(3,4-dihydroxyphenyl)-propionic acid, dihydrocaffeic acid, and 3,4-dihydroxyhydrocinnamic acid. Compound 2 has the following names: 3-(4-hydroxyphenyl)propionic acid and 4-hydroxyphenyl propionic acid. Compound 3 has the following names: benzenepropanoic acid, hydrocinnamic acid, and phenylpropanoic acid.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
2. Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites a method for preventing or ameliorating metabolic syndrome in a patient via preparing an anti-metabolic syndrome agent and administering the anti-metabolic syndrome agent. Claim 11 specifies the method for preventing or ameliorating metabolic syndrome according to claim 10, wherein the anti-metabolic syndrome agent inhibits cAMP phosphodiesterase activity and/or inhibits DPP IV activity. Anson (J Nutrition, 2011, 141(I), 137-143) teaches that phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid treat metabolic syndrome (Table 3, page 141). Further, Huang (Scientific Reports, 2019, 9(15585), 1-8) teaches phenolic compounds, such as compounds 1-3, inhibit DPP IV (page 8, paragraph 4). Additionally, Nishibe (Molecules, 2021, 26(2362), 1-21). teaches that phenolic compounds have activity against cAMP phosphodiesterase (abstract; page 2, paragraph 1). Accordingly, compounds 1-3 inherently possess activity against cAMP phosphodiesterase and DPP IV. Thus, the specified limitation of the anti-metabolic syndrome agent inhibits cAMP phosphodiesterase activity and/or inhibits DPP IV activity does not further limit the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
3. Claims 10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anson (J Nutrition, 2011, 141(I), 137-143) as evidenced by Huang (Scientific Reports, 2019, 9 (15585), 1-8) and Nishibe (Molecules, 2021, 26 (2362), 1-21).
Anson teaches bioprocessed bran increases bioavailability of phenolic acids in men and has activity against metabolic syndrome (abstract, page 141, column 1, paragraph 4; page 141, column 2, paragraph 1; Table 3, page 141).
Anson further teaches that whole grain consumption is linked to lower risk of metabolic syndrome, which is normally associated with a low-grade chronic inflammation and that bran is rich in phenolic acids (abstract). Additionally, Anson specifies preparation of bioprocessed bread for investigating effect of bioprocessing of bran in whole wheat bread on bioavailability of phenolic compounds, plasma antioxidant capacity, and anti-inflammatory potential (page 138, paragraphs 2, 4, and 5). Anson specifies phenolic compounds, phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid, and shows that the bioprocessed bread led to lower pro- to anti-inflammatory cytokine ratios than the control bread (Table 3, page 141; page 141, column 1, paragraph 2).
Regarding claim 10, Anson teaches a method for preventing or ameliorating metabolic syndrome in men in need of preventing or ameliorating metabolic syndrome comprising steps of: preparing an anti-metabolic syndrome agent comprising one or more active ingredients selected from the group consisting of compounds 1 to 3 represented by General Formula (I) (phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid) in the gastrointestinal tract, and administering an effective amount of the anti-metabolic syndrome agent to the patient for preventing or ameliorating metabolic syndrome (abstract; page 138, paragraphs 2, 4, and 5; page 141, column 1, paragraph 4; page 141, column 2, paragraph 1; Table 3, page 141).
Regarding claim 11, Anson teaches a method of preventing or ameliorating metabolic syndrome in a patient via preparation of anti-metabolic syndrome agents (phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid) via ingestion of bioprocessed bread (page 141, column 1, paragraph 4; page 141, column 2, paragraph 1; Table 3, page 141), as evidenced by Huang (Scientific Reports, 2019, 9 (15585), 1-8) and Nishibe (Molecules, 2021, 26 (2362), 1-21). Huang teaches phenolic compounds, such as compounds 1-3, inhibit DPP IV (page 8, paragraph 4), and Nishibe teaches that phenolic compounds have activity against cAMP phosphodiesterase (abstract; page 2, paragraph 1). Accordingly, compounds 1-3 inherently possess activity against cAMP phosphodiesterase and DPP IV. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). See MPEP § 2112(II). Thus, Anson teaches a method of preventing or ameliorating metabolic syndrome in a patient via preparation and administration of anti-metabolic syndrome agents that inhibit cAMP phosphodiesterase and/or DPP IV.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Anson (J Nutrition, 2011, 141(I), 137-143) in view of Nishitani (JP 2016-079186, published 16 May 2016, see IDS filed 14 Feb 2024).
Anson (J Nutrition, 2011, 141(I), 137-143) is applied as discussed in the 35 U.S.C. 102 rejection above.
The Examiner notes the relevant teachings with respect to claims 10 and 11 are set forth above and are incorporated herein by reference.
Additional relevant teachings are set forth below.
Anson teaches a method of preventing or ameliorating metabolic syndrome via preparation of compounds 1-3 in the gastrointestinal tract and administration thereof.
Regarding claim 12, Anson fails to teach the anti-metabolic syndrome agent is an oral composition.
Nishitani teaches pharmaceutical compositions and methods of preventing or ameliorating insulin resistance (metabolic syndrome as defined by Cleveland Clinic; see claim interpretation) via coffee polyphenols (akin to compounds 1-3):
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, which inhibit cAMP phosphodiesterase and DPP IV ([0001], [0004], [0005], [0008], [0052], and [0053]).
It would have been prima facie obvious to one or ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the pharmaceutical composition for ameliorating or preventing insulin resistance via coffee polyphenols of Nishitani to develop a method of preventing or ameliorating via administration of compounds 1-3:
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, to arrive at instant claim 12. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Anson teaches bioprocessed bran increases bioavailability of phenolic acids in men and has activity against metabolic syndrome,
-Anson teaches that whole grain consumption is linked to lower risk of metabolic syndrome, which is normally associated with a low-grade chronic inflammation and that bran is rich in phenolic acids,
-Anson teaches preparation of bioprocessed bread for investigating effect of bioprocessing of bran in whole wheat bread on bioavailability of phenolic compounds, plasma antioxidant capacity, and anti-inflammatory potential,
-Anson teaches phenolic compounds, phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid, and shows that the bioprocessed bread led to lower pro- to anti-inflammatory cytokine ratios than the control bread,
-Nishitani teaches dihydroferulic acid,
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, which is similar in structure to compounds 1-3, and inhibits cAMP and DPP IV ([0001], [0004], [0005], [0008], [0052], and
-Nishitani teaches oral compositions useful in treatment of insulin resistance ([0005], [0053]).
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of preventing or ameliorating metabolic syndrome via administration of an oral composition of anti-metabolic agent: compounds 1-3.
Regarding claim 13, Nishitani teaches the anti-metabolic agent is suitable for blending into cosmetic or hair cosmetics ([0097], [0098]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
5. Claims 10 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 17/764,666 (reference application) in view of Anson (J Nutrition, 2011, 141(I), 137-143) as evidenced by Cleveland Clinic (page 2, bullet points 4-5; “Metabolic Syndrome,” Cleveland Clinic, 13 Sept 2023, <my.clevelandclinic.org/health/diseases/10783-metabolic-syndrome>, accessed 14 Jan 2026), Huang (Scientific Reports, 2019, 9(15585), 1-8) and Nishibe (Molecules, 2021, 26(2362), 1-21). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 17/764,666 claims a method of lowering blood pressure in a patient via preparing a blood pressure-lowering agent and administering said agent:
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(claim 6 of ‘666). ‘666 teaches a method of preventing or ameliorating metabolic disease, because high blood pressure is a condition of metabolic disease, as evidenced by Cleveland Clinic (page 2, bullet points 4-5; “Metabolic Syndrome,” Cleveland Clinic, 13 Sept 2023, <my.clevelandclinic.org/health/diseases/10783-metabolic-syndrome>, accessed 14 Jan 2026).
Regarding claim 10, ‘666 fails to teach compounds 1-3.
Anson teaches a method for preventing or ameliorating metabolic syndrome in a patient in need of preventing or ameliorating metabolic syndrome comprising steps of: preparing an anti-metabolic syndrome agent comprising one or more active ingredients selected from the group consisting of compounds 1 to 3 represented by General Formula (I) (phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid), and administering an effective amount of the anti-metabolic syndrome agent to the patient for preventing or ameliorating metabolic syndrome (abstract; page 138, paragraphs 2, 4, and 5; page 141, column 1, paragraph 4; page 141, column 2, paragraph 1; Table 3, page 141).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the method of preventing or ameliorating lowering blood pressure (and thus metabolic syndrome) via administration of a polyphenol of ‘666 to develop a method of preventing or ameliorating metabolic syndrome via compounds 1-3 to arrive at instant claim 10. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘666 teaches dihydroferulic acid,
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, which is similar in structure to compounds 1-3,
-‘666 teaches compositions useful in lowering blood pressure (a condition in metabolic syndrome),
-Anson teaches bioprocessed bran increases bioavailability of phenolic acids in men and has activity against metabolic syndrome,
-Anson teaches that whole grain consumption is linked to lower risk of metabolic syndrome, which is normally associated with a low-grade chronic inflammation and that bran is rich in phenolic acids,
-Anson teaches preparation of bioprocessed bread for investigating effect of bioprocessing of bran in whole wheat bread on bioavailability of phenolic compounds, plasma antioxidant capacity, and anti-inflammatory potential, and
-Anson teaches phenolic compounds, phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid, and shows that the bioprocessed bread led to lower pro- to anti-inflammatory cytokine ratios than the control bread.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of preventing or ameliorating metabolic syndrome via administration of compounds 1-3.
Regarding claim 11, Anson teaches a method of preventing or ameliorating metabolic syndrome in a patient via preparation of anti-metabolic syndrome agents (phenylpropanoic acid, 4-hydroxyphenyl propionic acid, and 3(3,4-dihydroxyphenyl)-propionic acid) via ingestion of bioprocessed bread (page 141, column 1, paragraph 4; page 141, column 2, paragraph 1; Table 3, page 141), as evidenced by Huang (Scientific Reports, 2019, 9(15585), 1-8) and Nishibe (Molecules, 2021, 26(2362), 1-21). Huang teaches phenolic compounds, such as compounds 1-3, inhibit DPP IV (page 8, paragraph 4), and Nishibe teaches that phenolic compounds have activity against cAMP phosphodiesterase (abstract; page 2, paragraph 1). Accordingly, compounds 1-3 inherently possess activity against cAMP phosphodiesterase and DPP IV. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). See MPEP § 2112(II). Thus, Anson teaches a method of preventing or ameliorating metabolic syndrome in a patient via preparation and administration of anti-metabolic syndrome agents that inhibit cAMP phosphodiesterase and/or DPP IV.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Madeline M Dekarske whose telephone number is (571)272-1789. The examiner can normally be reached Monday - Thursday 10am - 4pm.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622